Albumin To Enhance Recovery After Acute Kidney Injury

Last updated: April 30, 2025
Sponsor: Ottawa Hospital Research Institute
Overall Status: Active - Recruiting

Phase

4

Condition

Kidney Disease

Vascular Diseases

Kidney Failure

Treatment

0.9% Normal Saline (100 mL)

20-25% Albumin fluid (100 mL)

Clinical Study ID

NCT04705896
CRF1819
  • Ages > 18
  • All Genders

Study Summary

Study objectives:

To determine whether, in critically ill patients with Acute Kidney Injury requiring renal replacement therapy (AKI-RRT), randomization to receive intravenous hyperoncotic albumin 20-25% (100 mL X two doses) compared to control/placebo normal saline boluses (100 mL X two doses) given during RRT sessions, leads to:

  1. An increase in organ support-free days (primary outcome) at 28 days following randomization; and

  2. An increase in RRT-free days (principal secondary outcome) at 28 days following randomization.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years old;

  • Admission to a critical care unit/intensive care unit (ICU) for > 24 hours;

  • Receiving vasoactive therapy AND/OR undergoing mechanical ventilation (includingnon-invasive mechanical ventilation (NIMV));

  • Immediate initiation of RRT for management of AKI is planned OR additional RRTsessions are imminently planned for patients who already received RRT during theirICU admission;

Exclusion

Exclusion Criteria:

  • Initiation of RRT for reasons other than AKI (e.g. drug intoxication, hypothermia) ;

  • Known pre-hospitalization end-stage kidney disease;

  • Kidney transplant within the past 365 days;

  • Presence or clinical suspicion of renal obstruction, rapidly progressiveglomerulonephritis, vasculitis, thrombotic microangiopathy or acute interstitialnephritis;

  • Advanced cirrhosis (Child Pugh class C [score 10-15]), spontaneous bacterialperitonitis or hepatorenal syndrome;

  • Acute peritoneal dialysis used as the initial RRT modality;

  • Contraindications to albumin:

  1. Admitted with traumatic brain injury

  2. Increased intra-cranial pressure in those with intra-cranial pressuremonitoring

  3. Prior history of anaphylaxis to intravenous albumin

  4. Contraindication or known objection to albumin/blood product transfusions

  • Already received 2 or more RRT sessions during ICU admission.

  • Limitations of medical therapy precluding RRT/mechanical ventilation/vasoactivemedications or plan to transition to palliation

Study Design

Total Participants: 856
Treatment Group(s): 2
Primary Treatment: 0.9% Normal Saline (100 mL)
Phase: 4
Study Start date:
November 02, 2023
Estimated Completion Date:
October 23, 2025

Study Description

Background: Severe Acute Kidney Injury that necessitates renal replacement therapy (AKI-RRT) is a frequent complication of critical illness and portends severe outcomes: high morbidity, an approximately 50% risk of in-hospital death, and increased healthcare resource utilization. Although life-saving when needed, RRT itself may contribute to the poor outcomes associated with AKI-RRT. Since RRT treatments frequently cause hypotension, repeated episodes of kidney and other organ ischemia may occur during RRT. Hypotension during RRT is often triggered by fluid removal. At the same time, there is some evidence that more aggressive ultrafiltration could be beneficial in AKI-RRT.

Albumin is a protein that is the primary contributor to the colloid oncotic pressure maintaining the effective circulating volume (ECV) during RRT. Critically ill patients with AKI-RRT are nearly always hypoalbuminemic. Despite its high cost and limited evidence to support the practice, intravenous hyperoncotic albumin is commonly administered to patients with AKI-RRT in an effort to boost the colloid oncotic pressure and maintain the blood pressure while simultaneously facilitating fluid removal

Objective:

This proposed trial is intended to provide definitive evidence as to the efficacy of a frequently used and expensive intervention to promote hemodynamic stability and augment ultrafiltration during RRT in critically ill patients

Design: A randomized controlled trial with two parallel arms. Setting: The mixed medical-surgical intensive care units of five Canadian tertiary care hospitals with plans to expand to include other centres across Canada and internationally.

Study Population: 856 patients admitted to the Intensive Care Unit (ICU) with AKI requiring treatment with RRT .

Intervention: Participants will be randomized 1:1 to receive either albumin (20-25%) boluses or normal saline placebo boluses at the start and halfway through RRT sessions in ICU, during their RRT treatments to a maximum of 14 days.

Connect with a study center

  • The Governors of the University of Calgary

    Calgary, Alberta
    Canada

    Site Not Available

  • University of Manitoba - Health Sciences Centre

    Winnipeg, Manitoba
    Canada

    Site Not Available

  • Nova Scotia Health Authority

    Halifax, Nova Scotia
    Canada

    Site Not Available

  • Hamilton Health Sciences Corporation

    Hamilton, Ontario
    Canada

    Active - Recruiting

  • Kingston General Hospital

    Kingston, Ontario K7L 2V7
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    North York, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • The Ottawa Hospital

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • University of Ottawa Heart Institute

    Ottawa, Ontario K1Y 4W7
    Canada

    Active - Recruiting

  • Scarborough Health Network

    Scarborough, Ontario
    Canada

    Site Not Available

  • Niagara Health System

    St. Catharines, Ontario L2S0A9
    Canada

    Active - Recruiting

  • Sinai Health System

    Toronto, Ontario M5G1X5
    Canada

    Active - Recruiting

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Site Not Available

  • Lakeridge Health

    Whitby, Ontario L1N 6K9
    Canada

    Site Not Available

  • Centre Integre de Sante et de Services Sociaux de Laval

    Laval, Quebec H7M3L9
    Canada

    Active - Recruiting

  • Centre hospitalier de l'Université de Montréal

    Montréal, Quebec H2X 3E4
    Canada

    Site Not Available

  • Centre Integre Universitaire de Sante et de Services Sociaux de L'Estrie - Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec
    Canada

    Active - Recruiting

  • University of Saskatchewan

    Saskatoon, Saskatchewan
    Canada

    Site Not Available

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